Description

Sulodexide is a highly purified glycosaminoglycan (GAG) mixture derived from porcine intestinal mucosa, primarily composed of fast-moving heparin and dermatan sulfate. This compound is valued for its endothelial-protective and antithrombotic properties, making it a critical active pharmaceutical ingredient (API) for vascular health. It is essential for pharmaceutical manufacturers developing treatments for chronic venous insufficiency, diabetic nephropathy, and other microvascular disorders. Our supply ensures the high purity and consistent biological activity required for reliable formulation and clinical efficacy.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable and oral formulations for vascular and endothelial therapy.
• Chronic Venous Insufficiency (CVI) Treatment: Key component in medications aimed at reducing edema, pain, and other symptoms associated with venous leg ulcers and venous stasis.
• Diabetic Complications: Utilized in developing treatments for diabetic microangiopathy, including nephropathy and retinopathy, due to its endothelial glycocalyx repair properties.
• Antithrombotic Agent: Employed in formulations targeting the prevention of thrombosis through its dual action on antithrombin III and heparin cofactor II.
• Research & Development: Serves as a standard reference in biochemical and pharmacological studies of glycosaminoglycans, endothelial function, and blood coagulation pathways.
• Veterinary Medicine: Potential application in veterinary pharmaceuticals for similar endothelial and circulatory disorders in animals.

Basic Information

Product Name	Sulodexide
CAS No.	57821-29-1
Molecular Formula	Mixture of Glycosaminoglycans (C12H19NO11S)n • (C14H21NO15S)n
Molecular Weight	~7,000 - 15,000 Da (Average)
Synonyms	Glycosaminoglycan Polysulfate; Fast-Moving Heparin Fraction; Dermatan Sulfate-Heparin Complex; Aterina; Vessel; Alfa Wassermann Sulodexide; GAGs Polysulfate; EMA 401 (related research code)
EINECS	Contact for details

Quality Control

Our Sulodexide is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, potency, and biological activity, consistent with pharmacopeial standards for heparinoid substances. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, specific activity, impurity profiles, and microbiological quality. We support compliance with cGMP, ICH Q7 guidelines, and relevant regulatory frameworks for active pharmaceutical ingredients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White or almost white powder
Identification (IR)	Conforms to reference spectrum
Identification (Electrophoresis)	Shows bands for fast-moving heparin and dermatan sulfate
Assay (Anti-Factor Xa Activity)	≥ 90% of labeled potency
Assay (Anti-Factor IIa Activity)	Specified range
Protein Content	≤ 1.0%
Nucleic Acid Content	≤ 0.5%
Loss on Drying	≤ 8.0%
Residue on Ignition	≤ 5.0%
Bacterial Endotoxins	< 5.0 IU/mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12 / USP <61>

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.